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Acrobat Coronary Stent System Effectiveness European Study (ACES)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PCI with Svelte Acrobat
PCI with other BMS
Sponsored by
Svelte Medical Systems Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CAD, PCI, BMS, Svelte, Acrobat, direct stenting, RCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible for PCI and demonstrating native vessel or vein/arterial graft disease
  • symptomatic CAD: either stable angina pectoris (CCS 1, 2, 3 pr 4) or unstable (Braunwald Class 1-3, B-C) or positive functional ischemia study
  • Male and post-menopausal female
  • Patient provides written informed consent prior to procedure
  • Patient willing to comply with protocol
  • Acceptable candidate for CABG
  • Patient indicated for stenting of one or more de novo stenotic lesions in native coronary arteries or bypass grafts with or without direct stenting
  • All target lesions for stenting in single or multi-vessel disease meet all inclusion criteria
  • None of the lesions requires stenting with Drug eluting stents
  • At least one lesion is visually estimated to be candidate for direct stenting
  • All target lesions for stenting have a visually estimatd RVD >= 2.5 mm and <= 3.5 mm
  • All target lesions for stenting are visually estimated to have LL =< 20 mm (to cover the lesion with 1 stent)
  • All target lesions for stenting visually estimated to have a stenosis > 50% and < 99%
  • All target lesions for stenting are ACS lesions TIMI flow >= 1

Exclusion Criteria:

  • Currently enrolled in another clinical trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  • A previous coronary procedure within 30 days
  • Any of the target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
  • Previous BMS deployment anywhere in the target vessel within the past 6 months
  • Any DES deployment anywhere in the target vessel within the past 9 months
  • Any previous stent placement within 10 mm (proximal or distal) of the target lesion
  • Patient has diabetes mellitus
  • Co-morbid condition(s) that could limit the patient's participation or impact the trial
  • Documented LVEF < 30% at the most recent evaluation
  • Evidence of AMI within 72 hours of the intended trial procedure and/or with TIMI flow 0
  • History of CVA or TIA in the last 6 months
  • Leukopenia (<3.5 x 10^9/L)
  • Neutropenia (<1000/mm3) <= 3 days prior to enrollment
  • Thrombocytopenia (<10^5/mm3) pre-procedure
  • Active peptic ulcer or active GI bleeding
  • History of bleeding diathesis or coagulopathy or inability to accept blood transfusions
  • Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated
  • Serum creatinine level > 2.5 mg per dl within 7 days prior to index procedure
  • In-stent restenosis
  • Patient not able to give consent or read or write or protected by law or under guardianship or deprived of civil rights
  • Woman of childbearing age
  • Patient not covered by health or social insurance
  • Unprotected left main CAD with obstruction > 50% , not protected by at least one non-obstructed bypass graft to the LAD or left circumflex (LCX) artery or their branches
  • Target vessel exhibiting multiple lesions > 40% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) to be stented based on visual estimate or on-line QCA
  • Any target lesion for stenting exhibits an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time
  • Any target lesion for stenting is excessively tortuous (two bends > 90° to reach the target lesion)
  • Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX
  • Any target lesion for stenting is has side branches > 2.0 mm in diameter in which bifurcation stenting is planned
  • Any target lesion >20 mm
  • Any target lesion totally occluded (CTO)
  • Any target lesion has TIMI flow = 0
  • Any target lesion with ISR

Sites / Locations

  • OLV Ziekenhuis
  • ZNA Middelheim - Hartcentrum
  • ZOL Sint Jan
  • CHU Liège - Sart Tilman
  • CHU Nord Grenoble - A. Michalon
  • AP-HP Hôpital Européen Georges Pompidou
  • AP-HP La Pitié Salpétrière
  • CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque
  • Clinique St Hilaire
  • CHU Rangueil
  • Clinique Pasteur
  • Hospital Universitari Vall d'Hebrón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acrobat

Control BMS

Arm Description

Device: PCI with Svelte Acrobat

Device: PCI with other BMS

Outcomes

Primary Outcome Measures

Proportion of patients free of Major Adverse Cardiac Event ("MACE-free patients")
Major Adverse Cardiac Event ("MACE") is defined here as device-oriented composite endpoint that includes, in hierarchical order: Cardiac death (All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established), Myocardial Infarction ("MI"), Target Lesion Revascularization ("TLR").

Secondary Outcome Measures

administered dye
Volume (ml) of administered dye i.e. injected radiological contrast medium.
procedure duration
Procedure duration (minutes) from arterial access to closure.
radiation exposure
Radiation exposure (gY/cm²) & total fluoroscopy time (min)
acute success
Acute success is measured at procedure end according to 4 criteria: Lesion success: Residual stenosis of the target lesion < 30% of the RVD using any percutaneous method. Direct stenting success: Lesion success without unplanned pre-dilation performed (planned pre-dilation is an exclusion criterion) from the trial. Device Success: Direct stenting success without post-dilatation or with post-dilatation using the Stent Delivery System (SDS). Procedure success: Lesion success & no in-hospital MACE
heparin administration
Amount of heparin administered during the procedure
adverse events
Adverse events occurrence: Death MI Repeat coronary revascularization Bleeding or vascular complications at discharge Stent thrombosis up to 6 months Other serious adverse events

Full Information

First Posted
December 12, 2012
Last Updated
August 25, 2014
Sponsor
Svelte Medical Systems Europe
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1. Study Identification

Unique Protocol Identification Number
NCT01761591
Brief Title
Acrobat Coronary Stent System Effectiveness European Study
Acronym
ACES
Official Title
Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Difficulty to identify eligible patients: 8 centers contributed 54 patients in 6 months.
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Svelte Medical Systems Europe

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.
Detailed Description
The main objectives of this study are to test the following hypotheses: The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE The evaluated stent is clinically beneficial compared to control BMS by reducing exposure to radiations, amount of contrast medium administered, procedure time, as well as amount of administered heparin, The evaluated stent does not result in more frequent adverse events than control BMS, The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS. Resource utilization (R.U.): Hospital-perspective resource utilization during the index admission and index procedure is not greater with evaluated the stent and potentially lower than with control BMS Resource utilization over a 6-month time-horizon, in relation to routine follow-up and MACE, is not greater with the evaluated stent than with control BMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, PCI, BMS, Svelte, Acrobat, direct stenting, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acrobat
Arm Type
Experimental
Arm Description
Device: PCI with Svelte Acrobat
Arm Title
Control BMS
Arm Type
Active Comparator
Arm Description
Device: PCI with other BMS
Intervention Type
Device
Intervention Name(s)
PCI with Svelte Acrobat
Intervention Description
Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System
Intervention Type
Device
Intervention Name(s)
PCI with other BMS
Intervention Description
Percutaneous coronary intervention with any other routine use CE marked bare metal stent (BMS) implantable either via direct stenting or after lesion pre-dilation
Primary Outcome Measure Information:
Title
Proportion of patients free of Major Adverse Cardiac Event ("MACE-free patients")
Description
Major Adverse Cardiac Event ("MACE") is defined here as device-oriented composite endpoint that includes, in hierarchical order: Cardiac death (All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established), Myocardial Infarction ("MI"), Target Lesion Revascularization ("TLR").
Time Frame
From the date and time of randomization until 6 months after the index procedure
Secondary Outcome Measure Information:
Title
administered dye
Description
Volume (ml) of administered dye i.e. injected radiological contrast medium.
Time Frame
intra-procedural
Title
procedure duration
Description
Procedure duration (minutes) from arterial access to closure.
Time Frame
intra-procedural
Title
radiation exposure
Description
Radiation exposure (gY/cm²) & total fluoroscopy time (min)
Time Frame
intra-procedural
Title
acute success
Description
Acute success is measured at procedure end according to 4 criteria: Lesion success: Residual stenosis of the target lesion < 30% of the RVD using any percutaneous method. Direct stenting success: Lesion success without unplanned pre-dilation performed (planned pre-dilation is an exclusion criterion) from the trial. Device Success: Direct stenting success without post-dilatation or with post-dilatation using the Stent Delivery System (SDS). Procedure success: Lesion success & no in-hospital MACE
Time Frame
procedure to discharge
Title
heparin administration
Description
Amount of heparin administered during the procedure
Time Frame
intra-procedural
Title
adverse events
Description
Adverse events occurrence: Death MI Repeat coronary revascularization Bleeding or vascular complications at discharge Stent thrombosis up to 6 months Other serious adverse events
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
resource utilization
Description
Resource utilization (R.U.) endpoints: Overall procedural and follow-up R.U. including: Man-time Facility usage Amount of medical devices and drugs used: during index procedure after index procedure until discharge between discharge and 6-month follow-up
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible for PCI and demonstrating native vessel or vein/arterial graft disease symptomatic CAD: either stable angina pectoris (CCS 1, 2, 3 pr 4) or unstable (Braunwald Class 1-3, B-C) or positive functional ischemia study Male and post-menopausal female Patient provides written informed consent prior to procedure Patient willing to comply with protocol Acceptable candidate for CABG Patient indicated for stenting of one or more de novo stenotic lesions in native coronary arteries or bypass grafts with or without direct stenting All target lesions for stenting in single or multi-vessel disease meet all inclusion criteria None of the lesions requires stenting with Drug eluting stents At least one lesion is visually estimated to be candidate for direct stenting All target lesions for stenting have a visually estimatd RVD >= 2.5 mm and <= 3.5 mm All target lesions for stenting are visually estimated to have LL =< 20 mm (to cover the lesion with 1 stent) All target lesions for stenting visually estimated to have a stenosis > 50% and < 99% All target lesions for stenting are ACS lesions TIMI flow >= 1 Exclusion Criteria: Currently enrolled in another clinical trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints A previous coronary procedure within 30 days Any of the target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.) Previous BMS deployment anywhere in the target vessel within the past 6 months Any DES deployment anywhere in the target vessel within the past 9 months Any previous stent placement within 10 mm (proximal or distal) of the target lesion Patient has diabetes mellitus Co-morbid condition(s) that could limit the patient's participation or impact the trial Documented LVEF < 30% at the most recent evaluation Evidence of AMI within 72 hours of the intended trial procedure and/or with TIMI flow 0 History of CVA or TIA in the last 6 months Leukopenia (<3.5 x 10^9/L) Neutropenia (<1000/mm3) <= 3 days prior to enrollment Thrombocytopenia (<10^5/mm3) pre-procedure Active peptic ulcer or active GI bleeding History of bleeding diathesis or coagulopathy or inability to accept blood transfusions Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated Serum creatinine level > 2.5 mg per dl within 7 days prior to index procedure In-stent restenosis Patient not able to give consent or read or write or protected by law or under guardianship or deprived of civil rights Woman of childbearing age Patient not covered by health or social insurance Unprotected left main CAD with obstruction > 50% , not protected by at least one non-obstructed bypass graft to the LAD or left circumflex (LCX) artery or their branches Target vessel exhibiting multiple lesions > 40% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) to be stented based on visual estimate or on-line QCA Any target lesion for stenting exhibits an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time Any target lesion for stenting is excessively tortuous (two bends > 90° to reach the target lesion) Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX Any target lesion for stenting is has side branches > 2.0 mm in diameter in which bifurcation stenting is planned Any target lesion >20 mm Any target lesion totally occluded (CTO) Any target lesion has TIMI flow = 0 Any target lesion with ISR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Fajadet, MD
Organizational Affiliation
Clinique Pasteur, 45 avenue Lombez, Toulouse 31300, France, Tel. 33 (0)5 62 21 16 99 - secretariat@interv-cardio-toul.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Schut
Organizational Affiliation
Svelte Medical Systems, Inc., 675 Central Avenue, New Providence, NJ 07974, USA, Tel. 1.908.264.2181 - aschut@sveltemedical.com
Official's Role
Study Director
Facility Information:
Facility Name
OLV Ziekenhuis
City
Aalst
ZIP/Postal Code
B-9300
Country
Belgium
Facility Name
ZNA Middelheim - Hartcentrum
City
Antwerpen
ZIP/Postal Code
B-2020
Country
Belgium
Facility Name
ZOL Sint Jan
City
Genk
ZIP/Postal Code
B-3600
Country
Belgium
Facility Name
CHU Liège - Sart Tilman
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
CHU Nord Grenoble - A. Michalon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
AP-HP Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
AP-HP La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Clinique St Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20357387
Citation
Piscione F, Piccolo R, Cassese S, Galasso G, D'Andrea C, De Rosa R, Chiariello M. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? Results from a meta-analysis of 24 randomised controlled trials. Heart. 2010 Apr;96(8):588-94. doi: 10.1136/hrt.2009.183277.
Results Reference
background
PubMed Identifier
22865317
Citation
Shao C, Stella PR, Agostoni P. Complex made easy: left anterior descending artery trifurcation lesion completely treated with a single device. J Invasive Cardiol. 2012 Aug;24(8):E164-6.
Results Reference
background
Citation
de Ribamar Costa J, Abizaid A, Stella P, Fernandez A, Granada J, Feres F, Serruys P. Preliminary results of the svelte trial: first-in-man assessment of the novel acrobat™ SOAW (Stent-On-A-Wire) coronary system. J Am Coll Cardiol. 2011;57(14s1):E1658-E1658. doi:10.1016/S0735-1097(11)61658-6
Results Reference
background

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Acrobat Coronary Stent System Effectiveness European Study

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